Trial Condition(s):

Multiple Sclerosis

EPID Multiple Sclerosis Pregnancy Study

Bayer Identifier:

18219

ClinicalTrials.gov Identifier:

NCT02749396

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult females in their childbearing ages. Little evidence is available regarding the association between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry. Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β products for comparison with the ongoing European IFN-β Pregnancy Registry.

Inclusion Criteria
:
 -  Women who have had a pregnancy with a recorded outcome consisting of an induced abortion, spontaneous abortion, ectopic pregnancy, or birth during the study period in FIN, SWE or NOR with the event being documented in the relevant databases.
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
2089
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Finland

Status
Completed
 

Trial Design